Dalilesen Impurity 61 CAS CATO-C4X-301061

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-301061
Molecular FormulaC18H24ClN3O2
Molecular Weight349.86 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Dalilesen Impurity 61 CAS CATO-C4X-301061 chemical structure

Description

Compared with other compounds in its class, the molecular weight of 349.86 g/mol gives Dalilesen Impurity 61 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

CATO supplies Dalilesen Impurity 61 (CAS CATO-C4X-301061), a pharmacopoeial impurity reference standard (molecular formula C18H24ClN3O2, MW 349.86 g/mol) used for the identification and quantification of trace impurities in APIs.

Dalilesen Impurity 61 (C18H24ClN3O2) contains a steroid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution. It is notably hygroscopic, halogen substitution raises its density and boiling point, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

This reference standard supports related-substances testing and method development in line with ICH Q3A/Q3B guidance on impurity control, and is suitable for system suitability testing and forced-degradation studies.

The assigned purity is verified by mass-balance and quantitative NMR (qNMR) approaches, with the expanded uncertainty reported at a 95% confidence level (k=2). Batch homogeneity and stability are independently assessed for every lot.

Physical & Chemical Properties

Molecular FormulaC18H24ClN3O2
Molecular Weight349.86 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor)
Purity97%+
StorageStore at 2-8°C, protect from light, keep sealed and dry
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)8.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentCl-containing
Nitrogen Atoms3

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